DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicants' response and amendments to the claims, filed 09/26/2025, are acknowledged and entered. Claims 1, 4, 7, 49, 53, 57, 61, 63-64, 79, 94-99, and 103-108 have been cancelled and claims 109-116 newly added by Applicant.
Claims 45, 100-102, and 109-116 are pending and under examination.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 45, 100-102, and 109-116 are rejected under 35 U.S.C. 103(a) as being unpatentable over EP 0 443 413 A1 (Published August 28, 1991), WO 2017/019951 A2 (Published February 2, 2017), and WO 2019/175902 A1 (Published September 19, 2019; Filed March 18, 2019) in view of EBRAHIMI ET AL. (“Topical tranexamic acid as a promising treatment for melasma”, J. Res. Med. Sci. 2014;19:753-7) and JAKHAR ET AL. (“Topical 5% tranexamic acid for acne-related postinflammatory erythema”, J. Am. Acad. Dermatol. June 2020;82:e187-8).
This is modified ground of rejection necessitated by Applicant’s amendments to claim 45 and newly added claims 109-116.
The amended claims circumscribe a composition comprising about 0.025% w/w tretinoin, tranexamic acid, and about 8% w/w azelaic acid (Claim 45) and further comprising a pharmaceutically acceptable vehicle (Claim 100). The composition is used in a method for the treatment of acne, photoaging, and/or uneven pigmentation, comprising administering to the skin of a subject the composition of claim 45 (Claim 101).
EP ‘413 teaches compositions comprising trans-retinoic acid (tretinoin) and azelaic acid having depigmenting and antiphotoaging effects (Abstract). Specifically, it teaches dermatologic preparations containing trans-retinoic acid (tretinoin) and azelaic acid as active ingredients and further comprising a pharmaceutically acceptable vehicle (p.2, l.1-2, l.24-27; p.3, l.1-28). It teaches administering to the skin of subjects a cream comprising 20% azelaic acid and retinoic acid in two different concentrations (0.01% and 0.025%) to evaluate antiphotoaging and depigmenting effects (p.3, l.29 to p.6, l.57).
WO ‘951 teaches pharmaceutical compositions comprising a first anti-acne compound, a second anti-acne compound, and an anti-photoaging compound for use in treating acne and photoaging (Abstract). Photoaging is taught to include fine wrinkles and “hyperpigmentation” (p.1, l.15-17). The first and second anti-acne compounds are selected from the group consisting of azelaic acid, clindamycin, niacinamide, tretinoin, and zinc pyrithione (p.3, l.15-19). The anti-photoaging compound is selected from the group consisting of azelaic acid, niacinamide, and ascorbyl acetate (p.3, l.20-22). The first anti-acne compound, the second anti-acne compound, and the anti-photoaging compound are three different compounds (p.3, l.23-24). It teaches a method for the treatment of acne and photoaging in a subject in need thereof comprising administering to the skin of the subject a composition comprising a first anti-acne compound, a second anti-acne compound, and an anti-photoaging compound, wherein the first and second anti-acne compounds are selected from the group consisting of azelaic acid, clindamycin, niacinamide, tretinoin, and zinc pyrithione, the anti-photoaging compound is selected from the group consisting of azelaic acid, niacinamide, and ascorbyl acetate, and the first anti-acne compound, the second anti-acne compound, and the anti-photoaging compound are three different compounds (p.3, l.25 to p.4, l.6). Regarding claim 102, it teaches a kit comprising a first anti-acne compound, a second anti-acne compound, and an anti-photoaging compound; a sealed container for housing the composition, and instructions for use (p.4, l.16-29).
WO ‘902 teaches a topical composition comprising 5% to 25% azelaic acid and 0.01% to 0.1% tretinoin, preferably with 1% to 5% vitamin C (Abstract). The compositions comprise a pharmaceutically acceptable vehicle, e.g., aloe vera gel (p.2, l.13-20). It teaches administering to the skin of subjects formulations of the invention to treat various skin ailments including acne (mild to moderate), hyperpigmentation (UV induced), skin aging, melasma, and rosacea (p.4, l.14 to p.5, l.15).
EP ‘413, WO ‘951, and WO ‘902 differ from the instant claims only in that they do not disclose the compositions taught therein further comprise tranexamic acid.
EBRAHIMI ET AL. teach tranexamic acid (TA) is claimed to have whitening effects especially for ultraviolet-induced hyperpigmentation including melasma (Abstract). They teach topical application a solution of 3% TA to melasma patients is an effective and safe medication for the treatment of melasma (Abstract).
JAKHAR ET AL. teach postinflammatory erythema (PIE) is a common sequala of acne inflammation (p.e187, first paragraph; Fig.1). They teach tranexamic acid (TXA) is known to decrease erythema by repressing proinflammatory cytokines (interleukin 6 and tumor necrosis factor a) and angiogenesis (p.e188). They teach topical TXA has to be formulated from the injectable TXA (500 mg/5 mL) by diluting with 0.9% sodium chloride solution to give a 5% TXA solution, which can be stored in an ethylene/propylene copolymer plastic container and can be given to the patient (Id.). They teach when given as a daily nighttime application, 5% topical TXA reduces erythema in 6 to 8 weeks (Id.; Fig.2).
It would have been obvious before the effective filing date of the application to combine about 0.025% w/w tretinoin, tranexamic acid, and about 8% w/w azelaic acid in a topical composition for use in the treatment of skin conditions such as acne and/or hyperpigmentation. The prior art teaches topical compositions comprising azelaic acid and tretinoin for use in treating various skin ailments including acne, hyperpigmentation (UV induced), skin aging, melasma, and rosacea (EP ‘413, WO ‘951, and WO ‘902). The prior art teaches topical compositions comprising tranexamic acid are an effective and safe medication for the treatment of melasma (EBRAHIMI ET AL.) and reduce postinflammatory erythema in patients with acne (JAKHAR ET AL.). A person of ordinary skill in the art would therefore have a had a reasonable expectation of success in formulating a topical composition comprising tretinoin, tranexamic acid, and azelaic acid. Such a topical composition would predictably be effective in treating acne, photoaging, and/or uneven pigmentation as evidenced by the combined teachings of the cited prior art.
It has long been held obvious to combine two known materials for their known function. In re Kerkhoven, 626 F.2d 846, 205 USPQ 1069 (CCPA 1980); In re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); In re Lindner, 457 F.2d 506, 173 USPQ 356 (CCPA 1972); In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971); In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960). In re Diamond and Kellman, 149 USPQ 562 (C.C.P.A. 1966), supports the obviousness of combining two drugs known to be useful for the same purpose. In Diamond, Appellants were claiming a combination of adenosine-5-monophosphate (A5MP) and a glucocorticoid. The Examiner cited prior art teaching that A5MP and glucocorticoids were known in the art to be useful for treating collagen diseases and that combining drugs for the treatment of disease is suggested by the prior art. Appellants argued that the combination of the two drugs is non-obvious since there is no teaching to combine these two out of all known anti-inflammatory agents. The Court was not persuaded by this argument, stating that:
“...we think it clear that it is a standard practice in this art to combine ingredients.”
Such is the case here. It is standard practice in the art of dermatology to combine active ingredients as evidenced by EP ‘413, WO ‘951, and WO ‘902, which all teach topical compositions comprising at least different active agents. For example, EP ‘413 teaches topical compositions comprising trans-retinoic acid (tretinoin) and azelaic acid having depigmenting and antiphotoaging effects. WO ‘951 teaches topical compositions comprising a first anti-acne compound, a second anti-acne compound, and an anti-photoaging compound, wherein the first and second anti-acne compounds are selected from the group consisting of azelaic acid, clindamycin, niacinamide, tretinoin, and zinc pyrithione, the anti-photoaging compound is selected from the group consisting of azelaic acid, niacinamide, and ascorbyl acetate, and the first anti-acne compound, the second anti-acne compound, and the anti-photoaging compound are three different compounds. WO ‘902 teaches a topical composition comprising 5% to 25% azelaic acid and 0.01% to 0.1% tretinoin, preferably with 1% to 5% vitamin C for the treatment of various skin ailments including acne (mild to moderate), hyperpigmentation (UV induced), skin aging, melasma, and rosacea. It would have been obvious to a person of ordinary skill in the art to add tranexamic acid to any of these topical compositions for its whitening effects in ultraviolet-induced hyperpigmentation including melasma and postinflammatory erythema reducing effects in patients with acne.
Regarding the newly added limitations of about 2% w/w or about 5% w/w tranexamic acid as recited in newly added claims 109-116, the cited prior art teaches topical administration of 3% and 5% tranexamic acid have therapeutic efficacy in treating melasma or erythema, respectively. Accordingly, the claimed about 2% w/w and about 5% w/w tranexamic acid would have been prima facie obvious to the person of ordinary skill in the art.
Response to Arguments
Applicant argues claim 45 has been amended to specify that the composition comprises about 0.025% w/w tretinoin and about 8% w/w azelaic acid. Applicant asserts that none of the cited references teach the limitations of claims 45 and 100-102 and the Examiner has not explained why these differences are obvious.
In response, WO ‘902 teaches a topical composition comprising 5% to 25% azelaic acid and 0.01% to 0.1% tretinoin for administering to the skin of subjects to treat various skin ailments including acne (mild to moderate), hyperpigmentation (UV induced), skin aging, melasma, and rosacea. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, the claimed “about 0.025% w/w tretinoin” and “about 8% w/w azelaic acid” fall squarely within the ranges expressly taught in the cited prior art and are therefore prima facie obvious. Further, Applicant has presented no evidence that the claimed amounts display any unexpected properties versus other amounts disclosed in the cited prior art. Rather, Applicant merely combines three known compounds in known amounts that are all disclosed to be useful for the same purpose(s).
Conclusion
Claims 45, 100-102, and 109-116 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 8:30 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
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